Tag Archives: Root Cause Analysis

Root Cause

Alleged Radiology Misreading Results in Removal of Cancer Patient’s Healthy Kidney

By ThinkReliability Staff

On January 17, 2013, a radiologist discussed the results of a CT scan with an urologist.  The CT scans identified cancer in the kidney of an urologist’s patient.  Two months later, the patient underwent surgery to remove the kidney.  The kidney was examined by a pathologist, who declared it cancer-free.  The wrong kidney had been removed, allegedly due to a misidentification by the radiologist.

Wrong-site surgeries like this one can lead to severe patient safety consequences, as well as severe financial and regulatory consequences for the doctors and healthcare facilities involved.  This is why surgery performed on the wrong body part has been identified as a “never event“, or an event that should never occur in a healthcare facility.

Even with this designation and the known seriousness of the issues, wrong-site surgeries continue to occur.  The Joint Commission estimates that the prevalence of wrong-site surgeries in the United States is as high as 40 per week.

Clearly, action must be taken to reduce the risk of wrong-site surgeries.  To identify areas of potential improvement, it can help to look at an example of an actual case of wrong-site surgery to determine lessons learned.  We will examine the case of the wrong kidney being removed as an example of issues that can lead to wrong-site surgeries using the Cause Mapping method of root cause analysis.

It’s important to identify the impacts to the goals as a result of an incident.  In this case, the patient safety goal was clearly impacted as the patient now has only 3/4 of a kidney remaining, with the potential to cause serious health impacts.  (A portion of the cancerous kidney was removed in a later operation.)  The compliance goal is impacted because of the occurrence of a “never event” as discussed above.  The patient services goal is impacted due to the removal of the wrong (healthy) kidney.  The radiologist and urologist involved in the issue have been sued for more than $1 million as a result of the issue.  If all these issues received similar lawsuits, the costs to the health system would be over $2B a year.

Once the impacts to the goals are identified, asking “why” questions develops the cause-and-effect relationships that led to the issue.  In this case, the removal of the wrong kidney is alleged to have resulted from the radiologist misreading the CT scan that identified the kidney with cancer and passing that information on to the urologist who performed the surgery.  Clearly the urologist’s physical exam (if any) did not adequately determine the site of the cancer.

To better understand the steps that led to the surgery, they can be diagrammed in a Process Map.  A Process Map lays out a process in much the same way that a Cause Map visually lays out cause-and-effect relationships.  A very high level overview of the process used in this case is shown on the downloadable PDF.  What’s important to note is that an incorrect reading of a CT scan or other diagnostic tool propagates through the process.  With no second opinions or double checks built in, the diagnosis of cancer in the left kidney was the only information the urologist had to determine the operating site.

There are of course other errors in the surgical preparation procedure that can also cause wrong-site surgeries.  (Many of these errors are identified in our proactive write-up on wrong-site surgeries.)  As stated by Mark R. Chassin, M.D., President of The Joint Commission, “Wrong site surgery events occur basically because none of the processes that we use in taking care of patients is perfect.”  Equally important is that the people performing the processes are not perfect.  Although both processes and people’s performance can be improved, it will never reach perfection.  For this reason, adding double checks and second opinions into processes is essential to reduce the risk of the one mistake resulting in a devastating patient safety impact.  In this case, having a second opinion on the CT scan, or having the physician re-identify the area with a physical exam prior to surgery (if possible) may have identified the error prior to removal of a healthy kidney.

View the Cause Map and process map by clicking on “Download PDF” above.

Root Cause

“Artificial Pancreas” May Dramatically Improve Management of Type 1 Diabetes

By Kim Smiley

As many as 3 million Americans have type 1 diabetes and for many managing the autoimmune disease requires constant vigilance.  Patients have to carefully monitor what they eat and their blood sugar levels, often pricking their fingers and injecting insulin multiple times a day.  The number of people diagnosed with type 1 diabetes has been increasing, but there is some good news.  There is no cure for type 1 diabetes, but a new device, an artificial pancreas, may make managing the disease significantly simpler.

Type 1 diabetes is caused when the immune systems attacks insulin-producing cells in the pancreas so the body can no longer produce adequate insulin.  Insulin is needed because it works to allow sugar to enter cells where it is used for energy, reducing the levels of sugar in the blood stream.  Sugar builds up in the blood when food is consumed and from natural processes in the body.  Without enough insulin, blood sugar levels will continue to increase.  High blood sugar can damage major organs and can have significant impacts on long-term health.  Low blood sugar is also dangerous and can quickly become a life-threatening emergency so patients with type 1 diabetes are constantly working to keep blood sugar within acceptable levels.

The artificial pancreas works by monitoring blood sugar levels every 5 minutes and using two pumps to deliver two different hormones (insulin to lower blood sugar levels and glucagon to raise blood sugar) as needed with minimum intervention required by the user.  The current version of the artificial pancreas consists of three parts (two small pumps and iPhone contacted to a continuous glucose monitor) but there are plans to simplify the device in the future.  The components connect to three small needles that are inserted in the patient to allow blood sugar levels to be monitored.  Insulin pumps currently used by many type 1 diabetics can only inject insulin and require more input from the user, so the artificial pancreas is a significant improvement over currently available technology.

The artificial pancreas is still in the development stage and needs additional testing and modification prior to becoming widely available for patient use.  The first test was done using about 50 patients (20 adults and 32 teenagers) who wore the new device for 5 days.  The results were very promising, but more testing will need to be done. During the 5-day test, the patients had lower blood sugar levels overall and the device simplified management of the disease.  Researchers reported that the patients didn’t want to return the devices because they worked so well. The next step is to have patients use the device for a longer time period.  It’s essential to ensure that the device is very robust, because the consequences can be dire if it fails.  Once the design is finalized, the hope is to seek FDA approval and have the artificial pancreas available in about 3 years.

To view a Cause Map of this issue, click on “Download PDF” above.

Root Cause

5.5 Million Cases of Norovirus are Spread Via Food Each Year

By Kim Smiley

Norovirus outbreaks on cruise ships may make exciting headlines, but the reality is that only one percent of norovirus outbreaks occur on the high seas.  About 20 million people in the US are sickened by noroviruses in the US each year and one of the most common transmission paths is via food.  Food-borne norovirus is estimated to be responsible for 5.5 million cases of norovirus annually in the US.

A Cause Map, a visual method for performing a root cause analysis, can be used to analyze this issue.  The first step in the Cause Mapping process is to determine how an issue impacts the overall goals and then the Cause Map is built by asking “why” questions to visually lay out the cause-and-effect relationships.  In this example, we’ll focus on the safety goal since it is clearly impacted by 5.5 million cases of norovirus transmitted via food.

So why are people getting norovirus from food?  This is happening because they are consuming contaminated food, predominantly at restaurants or catered events.  The food becomes contaminated when a food worker’s hands are contaminated by norovirus and they touch food, particularly food that is ready to serve and won’t be cooked prior to consumption.  (Disclaimer: You may want to stop reading here if you are eating or thinking about going to out to eat soon.)

For those unfamiliar with the illness, norovirus is basically a gastrointestinal nightmare that can cause the human body to do very messy things.  If a food service worker is ill, the virus can get on their hands, especially after using the bathroom.  According to a Centers for Disease Control and Prevention (CDC) report, the transmission of food-borne norovirus is “primarily via the fecal-oral route.”  And that is more than enough said about that.

It is also worth asking why food workers are at work if they are under the weather.  In the US, few food service workers get paid sick leave so they may show up at work sick because they are concerned about the loss of income and the impact on their jobs.  It’s also important to ensure that workers understand the importance of good hygiene and have access to both water and soap and time to effectively wash their hands.

The final step in the Cause Mapping process is to develop solutions to reduce the risk of the problem recurring.  The solutions to this problem are both simple in concept and difficult to effectively implement.  Ideally, food workers should stay home when they are ill and for at least 48 hours afterwards, but this is much easier said than done for many people.  Food workers should also wash their hands after using the bathroom and before handling any food, but it can be difficult to enforce the policy because employers and managers aren’t (and shouldn’t be) closely monitoring what happens during bathroom breaks.

To view a high level Cause Map of this issue, click on “Download PDF” above.

Root Cause

Lethal injection fails to quickly kill prisoner

By ThinkReliability Staff

While the use of the death penalty remains highly controversial, there is general agreement that if it is used, it should be humane.  The execution of a prisoner in Oklahoma on April 29, 2014 did not meet those standards.  The inmate died 43 minutes after the drugs were injected.  (Typically death takes 5-6 minutes after injection.)  According to Jay Carney, the White House Spokesperson, “We have a fundamental standard in this country that even when the death penalty is justified, it must be carried out humanely – and I think everyone would recognize that this case fell short of that standard.”

The details surrounding this case can be captured in a Cause Map, or visual root cause analysis, to examine the causes and effects of the issue.

The problem being evaluated is the botched execution of an inmate in the Oklahoma State Penitentiary. The execution began at 6:23 pm on April 29, 2014.  An important difference in this execution, compared to other executions, is that it was the first time the state had used the drug midazolam as part of the three-drug injection protocol.  The protocol, when originally developed in 1977, called for sodium thiopental, followed by pancuronium bromide and potassium chloride.

The safety goal was impacted in this case because of the failed execution.  The public service goal can be considered to be impacted as the execution was called off (after all three drugs were administered; the prisoner later died of a heart attack.)  The schedule goal is impacted because all future executions have been called off.  The state planned a two-week postponement of the next execution (scheduled for later the same day) in order for a review of this investigation to be completed, but at the time of this writing, that execution has not yet been scheduled.  Executions across the country have been appealed or stayed and none have taken place since April 29th.  The labor/ time goal is also impacted due to the investigation into the execution, which has not yet been published.

These goals were impacted due to the failure of the lethal injection.  The process intended to be used for this lethal injection is detailed on the downloadable PDF.  However, from the start things didn’t go smoothly.  Instead of using two IVs, one in each arm, only one IV was able to be connected, in the patient’s groin.  Because sodium thiopental is no longer available (drug companies will no longer provide it for use in lethal injections), the drug midazolam was used instead.  However, the protocol for using that drug is disputed.  In Florida, five times the amount of midazolam is used.  In Oklahoma, midazolam is used along with hydromorphone.  Because of the debate about lethal injection, most states don’t divulge their suppliers, so the efficacy of the drugs used cannot be verified.  In addition, there is generally at least one doctor present to oversee the executions, but these doctors are not usually identified and may not participate in the actual administration of the drugs because many medical organizations ban doctors from participating on ethical grounds.

At this point, it’s unclear what will happen at future executions.  The investigative report being prepared by the state of Oklahoma may give some suggestions as to how to make lethal injections more humane in the future, or this may tilt the scales towards ending lethal injection, or executions altogether.

To view the Outline, Cause Map, and Process Map, please click “Download PDF” above.

Root Cause

Two Los Angeles area nurses are stabbed the same morning at different hospitals by different attackers

By ThinkReliability Staff

The stabbing of a nurse that took place in a Los Angeles County, California hospital on April 20th, 2014, resulted in the serious injury of a nurse.  The danger of increasing violence and attacks within hospitals was demonstrated by this and an unrelated incident at another Los Angeles County hospital that happened later that same morning.  Both involved stabbings to nurses, though in the first case, the attacker used a knife after he bypassed security and in the second case, the attacker stabbed a nurse with a pencil.

By performing a root cause analysis of just one demonstrative case, solutions that can prevent similar issues (like the one that happened later that very day as well as many other recent cases of hospital violence) can be developed.  We will use Cause Mapping, a visual diagram of cause-and-effect relationships, of this case as an example of hospital violence.

The first step in the Cause Mapping process is to describe the what, when, and where of an incident, and define the impacts to an organization’s goals.  In this case, the employee safety goal is impacted by the serious injury to a nurse.  The patient safety goal is impacted by the potential for injury to a patient.  The patient services goal is impacted by the fact that a violent attacker was able to bypass a weapons screening area.  It’s unclear from the information available whether other goals were impacted in this case.  Once that is determined the “?” can be replaced with the actual impacts to the goals, or “none”.

It can be helpful to determine the frequency of a type of incident.  Clearly, since about seven hours passed between two stabbings of nurses within the same county in California, the frequency of these types of attacks is much too high.

Next, cause-and-effect relationships are determined by beginning with an impacted goal and asking “Why” questions.  In this case, the injury to the nurse was caused by multiple stabbings.  The stabbings resulted from the nurse encountering a violent attacker and were impacted by the response time.  (In this case, security was searching for the man after he bypassed the weapons screening and was alerted to his presence when the attacked nurse began to scream.)   It is unclear how the man was able to bypass the weapons screening station, but ideally improvements that would decrease the possibility of entrants bypassing it in the future will be implemented.

Violence within hospitals has been increasing over recent years, believed to be due to a number of factors.  In addition, nurses and other hospital personnel have noted the difficulty in determining the potential for an escalation of violence in patients and other visitors.  According to the President of the Emergency Nurses Association, Deena Brecher, R.N.,”You need to be able to recognize when things are starting to escalate.  We know our behaviors can help escalate a situation, not intentionally.”

Many nurses are calling for establishment of workplace violence plans that would provide nurses and other hospital workers tools to identify and de-escalate potentially violent behavior, as well as provide additional protections against these types of attacks.  Some hospitals have begun using a mobile distress system, such as a help button worn around the neck that allows a worker to request backup in a situation that feels unsafe.

These solutions bring up an interesting discussion about prevention and blame.  The solutions listed above all require action by the part of nurses or hospital workers.  Many organizations attempt to determine the person to “blame” for a situation, and then assign corrective actions accordingly.  Clearly, nobody is trying to imply that hospital workers are at fault for these violent attacks (blame) but are rather trying to provide tools within their sphere of control to reduce the risk of worker injury (prevention).  Preventing all people prone to violence from entering a hospital, while theoretically more effective at solving the problem, is neither practical nor possible.  Thus it is hoped that providing hospital workers additional tools will result in reduced injuries from hospital violence.

To view the Outline and Cause Map, please click “Download PDF” above.  Or view the Workplace Violence Prevention for Nurses course offered by the Centers for Disease Control and Prevention (CDC).

Root Cause

Concern Over Rising Costs of Specialty Drugs

By Kim Smiley

The good news is that more and more specialty drugs that show promise for treating serious medical conditions are becoming available.  The bad news is that some of these drugs are really expensive, both for insurance companies and individuals.

The new issues swirling around specialty drugs are illustrated well by the new drug for treating hepatitis C from Gilead Sciences.  The new drug is a significant improvement over previous treatment with a higher cure rate, a shorter duration and fewer reported side effects, but it carries an equally significant price tag.  The pills cost $1,000 each with a typical course of treatment costing $84,000.  The pills are in high demand and Gilead has reported a record breaking $2.3 billion in sales of their new hepatitis C drug during its first full quarter on the market.  But on the flip side, UnitedHealth Group, one of the largest US insurers, has reported it has spent $100 million to cover the hepatitis C drug and had their stock prices decrease.

An insurance company losing money may not seem like a source of concern, but more of the burden of the cost of specialty drugs is being passed along to patients as insurance companies figure out how to deal with the high price of specialty drugs.  Some insurance plans require patients to cover twenty percent of the cost of specialty drugs and 20 percent of $84,000 is beyond the means of many patients.  And some specialty drugs are even more expensive.  Also, financially healthy insurance companies are also vital if they are going to provide medical insurance at prices people can afford.

So why are these drugs so expensive? There are a number of factors that make specialty drugs so expensive.  One of them is that they generally treat a condition that relatively few people suffer from.  When more people take a particular drug, the development costs of the drug can be spread out and recouped over a larger population making the overall cost less for each individual.  The opposite occurs when there are fewer people who will take a particular medication: the development costs are more concentrated, making drugs for less common conditions more expensive in general.

There is also not usually a generic alternative available for specialty medication.  Many of the expensive specialty medications are newer and still protected by patents so that generics can’t be manufactured.  Most specialty medications are also biologics, meaning they are derived from living organizations, and they can’t be duplicated.  Medications with generic versions available tend to be chemically-based and easier to replicate.

Only time will tell how specialty medications will continue to shape the healthcare system, but their presence is only likely to grow as more drugs are developed.  Solutions will need to be developed to allow patients reasonable, affordable access to specialty medications, but also keep insurance and drug companies in business.

To see a Cause Map, or visual root cause analysis, of this issue, click on “Download PDF” above.

Root Cause

Hundreds Affected in ‘Unprecedented’ Ebola Outbreak

By ThinkReliability Staff

The ongoing Ebola epidemic in Africa is “unprecedented” due to its high mortality rate (up to 90%), geographic spread (at least 5 countries have reported cases of the disease, which has spread to urban areas as well), and difficulty enforcing quarantines that would reduce the spread.  As with many outbreaks, the factors involved are complex and wide-ranging.

We can address the issues contributing to the outbreak by capturing them in a Cause Map, or visual root cause analysis. This intuitive method ties impacted goals to cause-and-effect relationships, allowing development of solutions to all aspects of an issue.

First we begin with the impacts to the goals.  The outbreak began in Guinea at some point in early 2014, but was reported to the World Health Organization (WHO) on March 23, 2014.  The outbreak is still ongoing and has impacted Guinea the most, but has also spread to neighboring countries.  The strain involved is the Zaire Ebola virus, which is spread by bodily fluids.

At the date of publication, the virus has killed at least 101 out of 157 infected in Guinea alone.  The infections and deaths, as well as the spread of the disease, can be considered impacts to the public safety goal.  This is the first outbreak to have impacted urban Guinea, though there have been dozens of outbreaks in Africa over the past 40 years.

“Why” questions are used to determine the cause-and-effect relationships that resulted in the impacted goals.  Death typically results from bleeding or shock, which occurs due to infection with the virus and insufficient treatment. Infection results from the initial transmission (caused by eating raw infected meat), and the spread of the disease.  The spread in this case has resulted from the unusual migratory pattern, both because of the easy and frequent travel between countries but also due to an as-yet-unknown factor.  Normal outbreaks involve a much smaller geographic area.) Victims are contagious for a long time, meaning the disease is easily spread, and it has been difficult to enforce quarantine, because of mistrust of local authorities and foreign aid workers.  According to Stéphane Hugonnet  of WHO, “The mortality rate is extremely important.  Nine out of ten patients will die.  If we look at this from the population’s perspective, why would you go to a hospital if you have almost zero chance of getting out of it.”  However, with effective care, there is a chance of surviving Ebola.

However, providing that care is another challenge.  There is no cure for Ebola, possibly because financial incentives to develop a cure for a rare disease that primarily strikes poor African villages isn’t there. Care essentially involves keeping a person alive long enough for their body to be able to fight back, difficult in a country that has 0.1 physicians for every 1,000 people fighting a disease that rapidly replicates and – through an unknown mechanism – disables the immune system.

So what’s being done to end this outbreak?  Medical teams from Doctors without Borders (or Médecins Sans Frontières) and WHO have been dispatched to the area.   These medical teams may include anthropologists, to better address local concerns regarding the disease.  WHO has also recommended limiting personal contact and a on raw bush meat.  Meanwhile, researchers are working on a vaccine to prevent  transmission of Ebola.  It is hoped that these steps together will end this outbreak – and prevent future outbreaks as well.

To view the Outline, Cause Map and Solutions, please click “Download PDF” above.

Root Cause

CDC Finds that 1 in 25 Patients Acquire an Infection While in the Hospital

By Kim Smiley

A recent headline from the New York Times reads “Infections at Hospitals Are Falling, CDC Says”.  That sounds like fantastic news right?  Well, what about this one from the same day from the Washington Post: “One in 25 patients has an infection acquired during hospital stay, CDC says.”  One in 25 doesn’t seem like great odds to me.  The two headlines give very different impressions of the problem, so which one is right?

The truth is that both statements are accurate, but neither tells the complete story.  To really understand the situation, you need to read a lot more than just the headlines. This is a good analogy for what happens in meetings every day.  Something goes wrong and everybody thinks they know what THE problem is or what is THE root cause.  Many times when people argue they aren’t really in disagreement, they are just focused on different parts of the same puzzle.

Building a Cause Map, a visual format for performing a root cause analysis, can help reduce miscommunication.  The first step in the Cause Mapping process is to fill in an Outline.  The top of the Outline lists the basic background information.  At the bottom of the Outline, there is space for listing the specific impacts to the overall goals.  People may argue about what THE problem is, but it’s hard to argue when specifically listing how the problem impacts goals.  For example, most people would agree that increased cost of healthcare is an impact to the overall economic goal of a hospital.  It may sound counterintuitive, but adding detail helps clarify the situation, when defining the problem and when actually determining what went wrong.

In the case of those headlines listed above, both refer to a recent study by the Center for Disease Control and Prevention that found that about 1 in 25 patients in US hospitals in 2011 acquired at least one infection based on data from 11,282 patients treated at 183 hospitals in 10 states.   (The total number of patients who acquired at least one infection is over 700,000.) The study estimated that around 75,000 of these patients died, but didn’t provide information on whether the deaths directly resulted from the infections.  The study also didn’t include nursing homes, emergency departments, rehabilitation hospitals and outpatient treatment centers.  Previous estimates put the number of infections each year at 2.1 million in the 1970s and 1.7 million from 1990 through 2002. The rate of infections also varies widely from hospital to hospital.  There is uncertainty in the data available, but the trend seems to be going in the right direction, even though the problem of hospital-acquired infections remains significant.  Before working to reduce the risk of a problem, it’s important to lay out all the facts and understand what exactly the problem is.  That generally requires more than a simple statement, which is why the Cause Mapping uses a formal Outline to define a problem.

After the Outline is completed, the next step is to analyze the issue by building a Cause Map by asking “why” questions starting with one of the impacted goals.  Hospital acquired infections are an impact to the patient safety goal so we could begin by asking “Why are patients getting infections in hospitals?”  This occurs because they are exposed to a pathogen.  Why?  There are pathogens at the hospital because many sick people are there for treatment.  Inadequate cleanliness also plays a role.  Additionally, the pathogen is able to infect the patient.  You would continue asking questions to determine why patients are being infected until you reach the desired level of detail.  Generally, the bigger the problem, the greater level of detail is needed.

To view a completed Outline and a Cause Map of this issue, click on “Download PDF” above.

Root Cause

US Doctors Issue Statement That Mothers Should Avoid Water Births

By Kim Smiley

The number of water births in the United States has been increasing in recent years and controversy over their safety continues to rage.  The latest development is that the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists recently issued a joint statement saying that water births are not recommended and should be avoided, but some midwives and mothers disagree and adamantly defend the benefits of birthing in water.  The doctors agree that soaking in water during early labor may make the experience more pleasant for mothers, but feel that actual birth should be outside of the birthing tub.

One of the issues is that the benefits of water birthing are difficult to prove and the potential risks are difficult to quantify .  Some mothers believe that birthing in water helps relieve pain and can aid in a drug-free delivery.  Supporters of the practice also think that birthing in water can shorten labors, which reduces stress on the mother and the baby.  Some midwives have also expressed a belief that water births are gentler on babies, saying that many do not cry when they are born.  It’s difficult to definitively study the impacts of water births because birth outcomes depend on so many factors and you can’t do a double-blind study because it’s pretty much impossible to have a placebo for a water birth.

There have been reports of individual cases where something went wrong during a water birth, but there is little information on how often this occurs.  There is general agreement that complications are rare, but the doctors  releasing the statement feel the risk of complications outweighs the benefits.  The most serious concern is the baby drawing its first breath underwater, which could lead to breathing issues and even drowning.  There is also a risk of umbilical cord ruptures since the baby must be brought to the surface relatively quickly and the cord may be too short.  There is also increased risk of infection for the mother and baby since they are both exposed to potentially contaminated water because birth can get messy.

Until now, there has been little formal guidance provided about water births.  Providing more information for expectant mothers is a great first step, but disagreement between medical professionals about birthing methods can add confusion to an already stressful time.  Until more studies are done to provide a better understanding of the risks involved, women will have to rely on their own judgment and the guidance of their healthcare provider.

To view an Outline and Cause Map of this issue, please click “Download PDF” above.

Root Cause

New Studies Shed Light on Statin Side Effect Concerns

By Kim Smiley

Usage surveys have found that the majority of people prescribed statins in the United States discontinue using them within a year. The number one reason stated by patients for stopping statin use is concern with side effects.

This issue can be analyzed by building a Cause Map, a visual method for performing a root cause analysis.  The first step in the Cause Mapping process is to define the problem by filling an Outline with the basic background information (who, what, when, where, etc.).  Additionally, the Outline is used to capture how the problem impacts the goals so that the magnitude of the problem is well understood.   Once the Outline is complete, the analysis is done by building a Cause Map by asking “why” questions to find the causes that contribute to an issue.

For this example, the fact that patients aren’t taking prescribed statins is an impact to the patient goal.  This occurs because patients were prescribed statins and they are not using them.  Looking at each cause individually, let’s first ask why patients were prescribed statins.  A physician wrote a prescription for statins because the patient was considered at risk for heart disease and statins can reduce the risk of heart disease.  Statins have been shown to reduce cholesterol levels in the blood and high cholesterol can lead to blocked arties that can contribute to heart disease.  Cholesterol is reduced because statins inhibit an enzyme in the liver that controls cholesterol production in the body and the majority of cholesterol is produced by the liver.

So the question that still needs to be answered is why aren’t patients taking their statins if they can reduce their risk of heart disease?  The most significant reason that patients are discontinuing statin use is because they are concerned about side effects and the concerns haven’t been adequately addressed. Patients are concerned about side effects because they believe they have experienced side effects or they are generally worried about potential side effects.

Like most other medications, statins can have serious side effects, such as liver injury, cognitive impairment and potential for muscle damage (especially when combined with certain other medications.  According to the U.S. Food and Drug Administration, the value of statins in preventing heart disease has clearly been established and the benefits outweigh the risks, but one of the reasons that patients are concerned about side effects is that there are very outspoken critics of statins that do not agree with this assessment.  For the purpose of this example, we will assume that the FDA is correct that patients would benefit from taking statins if they are prescribed and that it is in fact a problem if patients discontinue using stating when their physicians have recommended them.

The final step in the Cause Mapping process is to come up with solutions that can be implemented to help reduce the risk of a problem occurring in the future. So how can the risk that patients will discontinue statins be reduced?  One possible solution would be to give patients reliable information that shows that statins are relatively safe and are effective at reducing the risk heart disease.  If patients believe that the benefits of statins outweigh the risks, they will be significantly more likely to take them.  More information is becoming available as researchers continue to study the benefits of statins and the frequency and severity of side effects.  For example, a recent study that used 83,000 patients and randomized statin therapy and a placebo found that “only a small minority of symptoms reported on statins are genuinely due to the statins: almost all would occur just as frequently on placebo”.  With more data about the effectiveness of statins and the accurate information the risks associated with them patients can make decisions based on real data and better determine if they should keep taking the statins.

To view the Outline and Cause Map, please click “Download PDF” above.